MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45541-CURVC
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during picc insertion, inserter met resistance around 25 cm of catheter inserted.Manoeuvring techniques were used to advance the picc unsuccessfully.The stylet wire was attempted to be removed and resistance met.Wire was fully retrieved and noted to be bent around 3 cm.Stylet wire exchanged with new accessory wire and picc unable to be advanced.Inserter then tried to remove picc and was unable remove.Picc could not be flushed however wire could be removed.As the peel away sheath was broken and removed the picc catheter finally gave way and could be removed.Catheter, stylet, introducer all saved for review.There was a noticeable bend in the catheter around 8cm mark.Associated complaints 9680794-2024-00092.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during picc insertion, inserter met resistance around 25 cm of catheter inserted.Manoeuvring techniques were used to advance the picc unsuccessfully.The stylet wire was attempted to be removed and resistance met.Wire was fully retrieved and noted to be bent around 3 cm.Stylet wire exchanged with new accessory wire and picc unable to be advanced.Inserter then tried to remove picc and was unable remove.Picc could not be flushed however wire could be removed.As the peel away sheath was broken and removed the picc catheter finally gave way and could be removed.Catheter, stylet, introducer all saved for review.There was a noticeable bend in the catheter around 8cm mark.Associated complaints 9680794-2024-00092 and 9680794-2024-00155.
Additional Manufacturer Narrative
(b)(4).The customer returned one catheter and peel away sheath for analysis.The peel away sheath was returned advanced over the catheter.Definite signs of use were observed.Visual analysis of the catheter revealed that it contained a natural bend along the entire body; however, no unintended kinking/bending was observed.No obvious kinking or bending was observed at the 8cm mark.The distal end of the catheter was also noted to be intentionally severed.The overall length of the catheter measured 46.2cm which is not within the specification limits of 55.85 - 57.76cm per the catheter product drawing.This indicates that at least 9.65cm of the catheter was severed and not returned for analysis.The outer diameter of the catheter measured 0.059" which is within the specification limits of 0.058 - 0.061" per the extrusion product drawing.The inner diameter of the catheter at the severed region measured 0.039" which is within the specification limits of 0.039 - 0.042" per the extrusion product drawing.A lab inventory guide wire was inserted through the catheter with a tortuous path introduced in the catheter body as would be in the human anatomy.The guide wire was able to pass completely through the assembly with minimal resistance.Performed per ifu statement, "if 80 cm guidewire is used, insert guidewire into distal lumen until soft tip of guidewire extends beyond catheter tip.Advance guidewire/catheter as a unit through peel-away sheath to final indwelling position, while maintaining position of distal end of guidewire.If 130 cm guidewire is used, insert soft tip of the guidewire through peel-away sheath to desired depth.Thread catheter over guidewire and advance catheter over guidewire to final indwelling position using image guidance or fluoroscopy." the catheter was also advanced through the returned peel away sheath.The entire catheter was able to pass through the sheath with little to no resistance.Performed per ifu statement, "insert catheter through peel-away sheath to final indwelling position." a device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs the user, "prepare guidewire for insertion by wetting guidewire with sterile normal saline for injection.Ensure that guidewire remains lubricious until it is inserted into patient/catheter." the ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the customer report of a kinked catheter was not confirmed through investigation of the returned sample.Visual analysis revealed no obvious kinking or bending of the catheter.The catheter additionally passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the sample received and investigation performed, no problem was found.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18710058
• Report Number: 9680794-2024-00155
• Device Sequence Number: 8192696
• Product Code: LJS
• UDI-Device Identifier: 10801902208726
• UDI-Public: 10801902208726
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/24/2025
• Device Catalogue Number: DLX-45541-CURVC
• Device Lot Number: 33F23G0488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown